Christine Robles

Regulatory Affairs Pharmacist with over 7 years of experience in regulatory compliance, product registration, and documentation management within the medical device industry. Proven ability to independently manage end-to-end regulatory processes, including preparation of submissions, dossier compilation, and ensuring compliance with requirements of the Food and Drug Administration Philippines and other applicable regulations. Experienced in directly coordinating with overseas suppliers and manufacturers to obtain, verify, and maintain regulatory documentation, ensuring timely product registration and continued market authorization.

Open to opportunities across different centers, with a strong commitment to expanding expertise and contributing to broader regulatory functions.

Regulatory Pharmacist at Phil Capital Trading Solutions Inc. (2023-08 – Present)

• Prepare and submit product registrations, notifications, and regulatory applications to the Philippine FDA.
• Ensure compliance with FDA Philippines regulations, ASEAN regulatory requirements, and applicable health authority guidelines.
• Review and verify technical documentation, product information, labeling, and packaging to ensure regulatory compliance prior to submission.
• Compile and manage regulatory dossiers and supporting documentation for medical devices and regulated products.
• Monitor regulatory application status and coordinate with regulatory authorities regarding submission updates and requirements.
• Identify documentation gaps, inconsistencies, or errors and coordinate with internal teams for necessary corrections.
• Maintain organized regulatory records and documentation systems to support audits and regulatory inspections.
• Track regulatory changes and support regulatory intelligence activities to ensure ongoing product compliance.

Regulatory Pharmacist at S & S Enterprises Inc. (2019-02 – 2023-06)

Community Pharmacist at Farmacia Ni Dok (2017-12 – 2018-12)

• Dispensed prescription and over-the-counter medications
• Provided patient counseling on proper medication use
• Managed inventory and ensured availability of medicines

Bachelor of Science in Pharmacy – Centro Escolar University – Malolos, Bulacan (2017 – 2017)

Pharmacist Licensure Examination (2017-08 – 2017-08)